Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.

FDA DeterminedCause 2

DESIGN: Software Design

Action

Roche sent an "Urgent Medical Device Correction" (UMDC) notification letter dated July 16, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Roche Molecular Systems, Inc. has disabled this software on affected Roche platforms and discontinued the distribution of the affected software. Contact Roche Diagnostic Technical Support, 24 hours a day, seven days a week at phone number : 1-800-428-2336 if you have questions regarding this notification.
For questions regarding this recall call 908-253-7569.